Oxycodone And Aspirin

ANDA 91670, held by Dr Reddys Labs SA. Aspirin; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 91670 (Oxycodone And Aspirin), held by Dr Reddys Labs SA, was first approved by FDA on Mar 16, 2011, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 16, 2011
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Mar 16, 2011	Original application	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxycodone And Aspirin325MG;4.8355MG · tablet;oral	Aspirin; Oxycodone Hydrochloride	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Apr 28, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Feb 26, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Oct 8, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Sep 20, 2018	Supplement 4Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 2REMS	Approved	None posted
Mar 16, 2011	Original application	Approved	REMS

Identifiers

Application: ANDA 91670
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters